Heart Valve Implant Orientation Markers for Fluoroscopic Alignment
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Solution Overview
Problem
Existing replacement heart valve implants face challenges in accurately aligning and securing the expandable framework relative to the native heart valve during implantation, particularly under fluoroscopic guidance, which can affect the success of the procedure.
Innovation Solution
The system includes a stent holder with radiopaque markers that indicate the correct rotational orientation of the implant by forming a visible symbol under fluoroscopy, which engages the attachment tab of the expandable framework, and the attachment tab, to secure the replacement heart valve implant to the implant delivery system, ensuring precise alignment and orientation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If radiopaque markers are added to indicate rotational orientation, then alignment precision is improved, but device complexity increases
Solution Approach 1:
The patent applies radiopaque markers that appear as distinct symbols (such as arrows or letters) under fluoroscopic imaging. These markers provide visual orientation cues that enable precise rotational alignment of the expandable framework relative to the native heart valve, while the markers are integrated into the existing structure without adding significant complexity
Solution Approach 2:
The radiopaque markers serve as an intermediary visual reference system between the implant components and the fluoroscopic imaging system. They translate the physical orientation of the implant into visible symbolic representations that guide alignment, resolving the contradiction by providing measurement precision through an added visual layer rather than through complex mechanical alignment mechanisms
2Reliability
If the stent holder engages the attachment tab to secure the implant, then reliability is improved, but ease of operation deteriorates
Solution Approach 1:
The attachment tab and corresponding engagement feature in the stent holder are designed with asymmetric geometries that provide directional engagement. This ensures reliable securement of the replacement heart valve implant to the delivery system while maintaining straightforward axial alignment during the implantation procedure, as the asymmetric features naturally guide correct orientation without requiring complex manipulation
Data Source
AI summary
A replacement heart valve system includes a replacement heart valve implant including an expandable framework and a plurality of leaflets, wherein the framework includes an attachment tab extending upstream from an inflow end, and an implant delivery system including an implant holding portion including a stent holder configured to engage the attachment tab to axially secure the implant relative to the delivery system. The stent holder includes a first radiopaque marker, and the attachment tab includes a second radiopaque marker, the first and second markers may collectively indicate a rotational orientation of the framework relative to a native heart valve under fluoroscopy. The first radiopaque marker may indicate when a middle commissure post of the framework is disposed in a posterior position and an anterior position relative to a native heart valve under fluoroscopy in a 3-cusp view.